Development and evaluation of very brief interventions (VBIs) to increase physical activity in primary care

Aim of the VBI Programme To develop and evaluate very brief interventions (VBIs) to increase physical activity that could be delivered by a practice nurse or health care assistant in a Health Check or other primary care consultation

Development work Expert consultation Pilot trialSubstantive trial WS1 Evidence synthesis Estimate cost and effectiveness of promising VBIs WS2 Qualitative study Integration in NHS health checks Shortlist VBIsWS3 Pilot trial Develop and pilot materials Test feasibility, acceptability, fidelity, potential efficacy and cost WS4 Main trial Estimate cost and effectiveness of best- bet VBI WS5 Health economics Resource use of promising VBIs Economic model of cost- effectiveness of VBIs Select best-bet VBI

VBI Programme Team Stephen Sutton (PI, Director) Wendy Hardeman (Deputy Director) Laura Lamming, Dan Mason (WS1) Philip Miles, Simon Cohn (WS2) Katie Morton, Sally Pears, Maaike Bijker, Richard Parker (WS3) Ann Louise Kinmonth, Gillian Orrow, Sue Boase Simon Griffin, David Ogilvie Janet Watkinson Ed Wilson, Vijay Singh GC, Marc Suhrcke (WS5) Toby Prevost PPI Panel National Institute for Health Research (funder)

Development work Expert consultation Pilot trialSubstantive trial WS1 Evidence synthesis Estimate cost and effectiveness of promising VBIs WS2 Qualitative study Integration in NHS health checks Shortlist VBIsWS3 Pilot trial Develop and pilot materials Test feasibility, acceptability, fidelity, potential efficacy and cost WS4 Main trial Estimate cost and effectiveness of best- bet VBI WS5 Health economics Resource use of promising VBIs Economic model of cost- effectiveness of VBIs Select best-bet VBI

Background Evidence for very brief interventions (VBIs) to increase physical activity has not been reviewed. 1.What is a very brief intervention? (Undefined in PA literature) “delivered face-to-face, preferably in a single session lasting no more than 10 minutes, but possibly also multiple brief sessions and/or distance contacts such as leaflets or telephone calls” 2.How can we find very brief interventions?  No formal definition – potentially difficult to search for primary studies.  Multiple reviews of PA interventions – review of reviews.

Objectives of the systematic review 1.To determine and describe the current working definition of a ‘very brief intervention’ in the physical activity intervention review literature. 2.To summarise what is known about very brief interventions to increase physical activity that could be delivered face-to- face in a primary care or community setting. 3.To assess and make recommendations for the reporting of interventions.

Methods Review Level:  Review of physical activity interventions only (single risk factor)  Systematic review/Meta-analysis  Adults  Not PA rehabilitation Data extraction Standardized proforma. Double checked by second researcher. High heterogeneity Narrative Synthesis Inclusion criteria VBI study level: Individual level Face-to-face component Less than 10 minutes Physical activity outcome

Results: Study selection Records after duplicates removed N=5803 Records after duplicates removed N=5803 Records identified from ineligible comments: N=3 Excluded: N=5561 Excluded: N= 40 Excluded: N= 98 Excluded: N=88 Records identified from authors collection: N=4 For Title screening N=5803 For Abstract screening* N=242 For Full text screening* N=154 For VBI screening* N= 56 For Synthesis N= 16 reporting 15 separate reviews. No. of VBIs: 18 papers, reporting 13 separate studies evaluating 19 individual VBIs. Records identified from electronic databases: N=11993 * Double screened

Results: Preliminary synthesis Design and methods Characteristics of VBIs (13 studies) Summary of results Country 9 USA 1 NZ 1 Netherlands 1 UK 1 Australia Design 8/13 Randomised Setting 12 / 13 Primary care settings Providers 11 / 13 - GPs/Physicians/Family physicians/Primary care providers (excluding nurses) Population age 5/13 >/= ‘middle aged’ (primarily) Sample size Range = 63 – 874 Median ~ 355 Comparison 5 Usual care 2 Not reported 5 Intervention 1 Usual care + Intervention Follow up Median = 5 months. 8/13 reported ST follow up only (</=6 months). PA measures 3/13 Objective measures 12/13 Self report measures

Preliminary synthesis Intervention characteristics Characteristics of VBIs (19 VBIs) Summary of results Mode(s) of delivery19 / 19 - Individual face to face verbal 14 / 19 - Written materials 8 / 19 - Phone calls 4 / 19 - Computer Content19 Advice/counselling on increasing PA, sometimes stage based or tailored ; at least 2 based on pre-assessment. 14 Exercise prescriptions/educational materials/tip sheets or posters/stage based or tailored materials. 8 ‘Booster’ calls/exercise counselling calls/follow ups DurationRange = 2-10 minutes. Mode = 5 minutes.

EffectVBI content SampleControlFollow upMeasure Reports at least 1 positive effect of a VBI Advice. +/-Phone counselling.100 Int3/6 mos SR+Obj Assessment. Counselling, stage of change tailored goal setting, stage of change tailored written advice/tips. Booster phone call. (3 studies) 255** Usual care** 4-6 wks* SR+Obj, SR* Advice (prompted/unprompted), educational hand-out. 383 Usual care1 mo SR Assessment. Goal oriented advice +/- written prescription. Phone call. 491 Int6 wks SR Counselling. Mailed standard/ tailored pamphlet.763 Usual care1/6/(12 mos – NS) SR No effect of a VBI Computer delivered PACE+ counselling. +/- Booster mailings, phone calls. 173 Int1 wk, 4 mos SR Stage based/non stage based advice and materials, leisure pass. 294 Int+Usual care 2/6 mos SR Assessment. Stage specific advice, benefits, self- efficacy barriers, referral to community resources, prescription, manual. Follow up visit, phone calls, newsletters. (2 studies) 355, 63. Usual care6 wks, 8 mos & 1wk, 6 wks. SR Advice and encouragement. +/- Booster phone calls and additional counselling protocols. 358 Int8 wks, 6, 12 mos SR Assessment. Advice on national guidelines, referral to health educator for clarification and materials. 874 Int6, 12, 24 mos SR+Obj * = a study that did not report this detail.

Preliminary conclusions  Very few VBIs.  Content and delivery poorly specified.  Impact of quality on effectiveness?  Conflicting findings - no observable pattern between intervention design and effectiveness. Recommendations:  Comprehensive reporting of intervention characteristics.  More robust evaluations of VBIs.

Limitations & Next steps  Review of reviews – could have missed some VBIs.  Data extraction at the level of the review, not primary studies – more detail? ‘real’ VBIs? Next…  Synthesise data & double check

Methods: Search strategy Search strategy Key terms: “physical activity”, “exercise”, “increase”, “brief intervention”, “counselling”, “systematic review”, “meta analysis”. Period covered: October Databases  CINAHL  Cochrane Database of Systematic Reviews  Database of Abstracts of Reviews of Effects (DARE) on Cochrane Library and Centre for Reviews and Dissemination (CRD)  Health Technology Assessment database on Cochrane Library and Centre for Reviews and Dissemination (CRD)  Embase  MEDLINE  PsycINFO  SCI-Expanded  SSCI SIGN  Hand search of first authors’(LL) personal collections of articles

Dan Mason, Laura Lamming, Sally Pears, Katie Morton, Maaike Bijker, Ed Wilson, Vijay Singh GC, Stephen Sutton, Wendy Hardeman. The effectiveness of pedometers to increase physical activity: a systematic review and meta-analysis.

Current evidence Systematic review of pedometers to increase physical activity Bravata et al (2007) JAMA; 298:19; RCTs: pedometers increased steps by 2419±1394 per day 18 observational studies: increased steps by 2183±613 per day Lots of different study designs Interventions typically multi-component; do not isolate pedometer effect More studies now = greater power to examine heterogeneity

Additional vs residual components Additional components Substantial addition to pedometer e.g. PA counselling, access to PA website Pedometer NOT isolated if these vary between groups Residual components Instructions to increase PA Given a PA goal Asked to record daily PA Pedometer IS “isolated” if only these things vary between groups

Search MEDLINE: 1471 PsycINFO: 760 SCI-EXPANDED/SSCI/CPCI- S/CPCI-SSH: 1791 EMBASE: 1540 Cochrane: 371 ERIC: 34 CINAHL: 678 SCOPUS: 3107

Preliminary subgroup: select by measurement Objective physical activity measure Self-report physical activity measure N=27N=15N=26 Fitness outcomes only N=6

Preliminary subgroup: select by design Pedometer isolated e.g. “ped+X vs X” Pedometer not isolated e.g. “ped+X vs Y” N=23N=6N=45

Preliminary subgroup: final selection N=13 Objective physical activity measure Pedometer isolated e.g. “ped+X vs X” N=29 N=13 N=16

Residual intervention components Instructions varyLogging PA variesGoals vary Baker 2011 Carr 2008XXX Du Vall 2004XXX Gray 2009XX Hultquist 2007 McMurdo 2010 Ornes 2007X Samuels 2011 Sugden 2008 Vallance 2007X Yates 2009 Eastep 2004X Strath 2011XX

Results – pedometer effect isolated, N=13

Results – goal subgroups Results – step goal subgroup analysis, N=13 x 3 subgroups

Discussion Preliminary analysis suggests overall increase in physical activity in pedometer groups when (somewhat) isolated against a non-pedometer control Subgroup analyses possible on PA goals, PA logs, goal review etc. But these components are all correlated to some extent… Further studies to integrate with self-report measures Further data on intervention intensity

Development work Expert consultation Pilot trialSubstantive trial WS1 Evidence synthesis Estimate cost and effectiveness of promising VBIs WS2 Qualitative study Integration in NHS health checks Shortlist VBIsWS3 Pilot trial Develop and pilot materials Test feasibility, acceptability, fidelity, potential efficacy and cost WS4 Main trial Estimate cost and effectiveness of best- bet VBI WS5 Health economics Resource use of promising VBIs Economic model of cost- effectiveness of VBIs Select best-bet VBI

Research Action  Qualitative approach – Interview based – On-site at Health Centers et al – Observation of Health Check (HC) – Waiting Room ‘assessment’  Sample Size – 40 patient interviews and 4/5/6 practitioner interview  Interview Structure – minute, semi-structured, one-on-one, private setting

Field Work  6 locations  Time frame: January 27 th – March 27 th 2012  Morning and afternoon appointments  Not all nurses give consent to observation  Not all patients give consent (on the day)  Overall success / average interview time circa. 40 minutes

The Health Check  Health Check structure as observed: – Formulaic:  General health probing and structure of session  Weight and height/BMI  [‘VBI’ on PA generally at this stage] / Diet  Smoking  Alcohol  Blood Pressure  Risk Assessment  Bloods  General discussion/conclusion

Data Themes  The Health Check (HC) as a forum of general health  Self-selection  Expectations  Dynamics  Concerns

Data Themes (2)  The HC as ‘reassurance’  The HC as ‘truth’  The HC is not ‘expert’ but ‘confirmation’  The HC is not long enough – Detail – Advice – Insight

Data Themes (3)  HC is seen as merely a ‘first phase’ of a wider ‘consultation’ on health. – A reoccurring theme in all practices with all patients. – Average ‘Type’ – ‘Checks’ are ‘checks’, not a platform for ‘diagnosis’ – thus not a platform for solutions (or advice) – Empathy and Advice – Common sense should prevail at all times on how to look after yourself

Data Themes (4)  Advice – Advice not always present – Nurses/HCA’s often skip advice if patient ‘looks’ ok – Patients split on ‘best time’ for a ‘VBI’ on PA – at the time, or at the end. Sometimes both – with concluding statements aimed at ‘sending them out into the world’ with advice – Leaflets are unpopular – Advice is not seen as ‘part’ of the HC. Patients do not stress ‘advice’ as something that is ‘missing’ (like, for example, lung capacity testing)

Conclusion  VBI on Physical Activity: – Advice is patchy – Advice is not bespoke – Advice has even chance of ‘impact’ at end of meeting (as a composite) or attached to PA-theme during HC – PA is common sense – PA is activity

Development work Expert consultation Pilot trialSubstantive trial WS1 Evidence synthesis Estimate cost and effectiveness of promising VBIs WS2 Qualitative study Integration in NHS health checks Shortlist VBIsWS3 Pilot trial Develop and pilot materials Test feasibility, acceptability, fidelity, potential efficacy and cost WS4 Main trial Estimate cost and effectiveness of best- bet VBI WS5 Health economics Resource use of promising VBIs Economic model of cost- effectiveness of VBIs Select best-bet VBI

Development work Expert consultation Pilot trialSubstantive trial WS1 Evidence synthesis Estimate cost and effectiveness of promising VBIs WS2 Qualitative study Integration in NHS health checks Shortlist VBIsWS3 Pilot trial Develop and pilot materials Test feasibility, acceptability, fidelity, potential efficacy and cost WS4 Main trial Estimate cost and effectiveness of best- bet VBI WS5 Health economics Resource use of promising VBIs Economic model of cost- effectiveness of VBIs Select best-bet VBI

 Aim: To pilot and test promising VBIs in a pilot trial  Objectives: 1)To develop and pilot intervention protocols, training manual, intervention materials and quality assurance (fidelity) instruments 2)To test the fidelity, feasibility, acceptability and potential efficacy of the VBIs 3)To decide which single or combined VBI to take forward to evaluation in a substantive trial (WS4) Aim and objectives of WS3 Walk Dance Swim Run Stretch Cycle Move!

 Phase 1: Prototype ‘brief’ interventions will be piloted in three practices (n=180) using an iterative approach to assess feasibility and acceptability of the interventions:  Control Group: No control group.  Intervention Groups: Participants will receive one of four very brief interventions for increasing physical activity, for instance: (1) motivational counselling intervention OR (2) planning intervention OR (3) pedometer intervention OR (4) activity diary (self-monitoring) intervention VBI WS3: Study Design Walk Dance Swim Run Stretch Cycle Move!

 Phase 2: An individually randomised controlled trial will be conducted in 5-8 practices (n=500) to test the feasibility, acceptability and potential efficacy of up to 7 very brief interventions:  Control Group: Participants will receive the standard NHS Health Check.  Intervention Groups: Participants will receive the standard NHS Health Check PLUS one of (up to) seven very brief interventions for increasing physical activity, for example: (1) motivational intervention OR (2) planning intervention OR (3) pedometer intervention OR (4) activity diary intervention OR (5-7) a combination of interventions determined by the pilot testing in Phase 1 and the expert consultation (e.g., OR ). VBI WS3: Study Design Walk Dance Swim Run Stretch Cycle Move!

3. Consultation: with academics, commissioners, practitioners and end- users (the PPI, patient public involvement panel) on their experience of what techniques are likely to be both feasible and effective. 2. Qualitative Research of WS2: interviews with health care practitioners who deliver Health Checks, and with patients after they attended a health check. 1. Previous research: that has shown these techniques to be the most likely to bring about a change in physical activity (e.g. evidence that brief counselling, making specific plans, monitoring steps with a pedometer or diary have been effective at increasing physical activity). Development of the Very Brief Interventions The four very brief interventions have been designed and developed based on: Walk Dance Swim Run Stretch Cycle Move!

VBI 1: Motivational Counselling & Booklet Brief discussion of: PA recommendations. Physical activity assessment (Active or Under- Active). Benefits of increasing physical activity. Ways of increasing physical activity. Motivational Booklet: given to the participant to take away and encouraged to ‘give it a try’ for 4 weeks. Walk Dance Swim Run Stretch Cycle Move!

VBI 2: Planning Brief discussion of: PA recommendations. Physical activity assessment (Active or Under-Active). Activity Planning Sheet: participant asked to identify and write down a specific plan of how they might increase their physical activity. Given to the participant and encouraged to ‘give it a try’ for 4 weeks. Walk Dance Swim Run Stretch Cycle Move!

VBI 3: Pedometer Brief discussion of: PA recommendations (10,000 steps a day). Physical activity assessment (Active or Under- Active). Using a pedometer to measure steps walked. How to use and wear the pedometer. Pedometer Information Booklet: Given to the participant to take away and encouraged to ‘give it a try’ for 4 weeks. Walk Dance Swim Run Stretch Cycle Move!

VBI 4: Physical Activity Diary Brief discussion of: PA recommendations (10,000 steps a day). Physical activity assessment (Active or Under-Active). Activity Diary: – participant asked to identify and write down a physical activity goal for the next week. – participant shown how to monitor daily and weekly activity (as well as thoughts and feelings about the activity), and how to review goals each week.  Physical Activity Diary: Given to the participant to take away and encouraged to ‘give it a try’ for 4 weeks. Walk Dance Swim Run Stretch Cycle Move!

Thank you!